Large B-cell lymphoma lymphoma
Conditions
Interventions
Patients in this study are treated with oral Ven (800 mg once daily) and oral
Tam (starting with a ramp-up phase
2 days 10mg, 2 days 20mg, and 40mg once
daily). These doses are the approved doses for treatment of breast cancer (Tam)
and the advised dose for the treatment of B-cell Non-Hodgkin Lymphoma (NHL)
Sponsors
Universitair Medisch Centrum Groningen
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: • Patients of 18 years and older and under the age of 70 with a diagnosis of Diffuse Large B-cell lymphoma (according WHO 2016) and refractory after 2 lines of therapy for patients ineligible for CAR T-cell therapy and after CAR T-cell therapy (hence after 3rd line of therapy). Patients with relapsed/refractory DLBCL older than 70 years after at least 1 line of conventional chemotherapy or after CAR T-cell therapy. • Written informed consent. • No known allergy to Ven or Tam.
Exclusion criteria
Exclusion criteria: • Eastern Cooperative Oncology Group (ECOG) performance status >2 • Absolute neutrophil count (ANC)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Descriptive analyses of safety and toxicity (using SAE grade 3 and 4 listing) of tamoxifen and venetoclax | — |
Secondary
| Measure | Time frame |
|---|---|
| • To assess the effectivity of the combination Tam and Ven as measured by the day + 28 and +90 response as measured by FDG PET CT scan. • To assess the duration of response (DOR) • To assess the progression free survival (PFS) after 3 months (after the first dose of TAM) • To assess the overall survival (OS) after 3 months | — |
Countries
Netherlands
Outcome results
None listed